Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 8 January 2018
• Main ID: NCT01405196
• Date of registration: 27/07/2011
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus BUTTERFLY
• Scientific title: A Double-blind, Randomized, Placebo-controlled, Multicenter Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Systemic Lupus Erythematosus (Sle)
• Date of first enrolment: December 2011
• Target sample size: 183
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01405196
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Argentina, Chile, Colombia, Germany, Hungary, Korea, Republic of, Mexico, Moldova, Republic of, Peru, Poland, Puerto Rico, Romania, Taiwan, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female subjects between ages of 18 and 75 years old at time of signing
consent.

- Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American
College of Rheumatology (ACR) criteria.

- Have a unequivocally positive anti-nuclear antibody (ANA) test result.

- Active disease at screening defined by both: SLEDAI-2K score greater than or equal to
6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or
central nervous system) or BILAG B disease in more than or equal to 2 organ systems if
no level A disease in present.

Exclusion Criteria:

- Any prior history of treatment with PF-04236921, or anti-IL-6 agent;

- Have received any of the following within 364 days of day 1: a biologic
investigational agent other than B cell targeted therapy; required 3 or more courses
of systemic corticosteroids for concomitant conditions; history of previously
untreated or current evidence of active or untreated latent infection with
Tuberculosis (TB), evidence of prior untreated or currently active TB by chest
radiography, residing with or frequent close contact with an individual with active
TB.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lupus Erythematosus, Systemic

Intervention(s)

Biological: PF-04236921

Primary Outcome(s)

Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 24 [Time Frame: Week 24]

Secondary Outcome(s)

Change From Baseline in European Quality of Life 5 Dimensions Questionnaire (EQ-5D) at Week 4, 8, 12, 16, 20 and 24 [Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24]

Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Week 4, 8, 12, 16, 20 and 24 [Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24]

Number of Participants With Anti-drug Antibodies (ADAs) and Neutralizing Antibodies (Nabs) [Time Frame: Baseline up to Week 52]

Percentage of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, and 20 [Time Frame: Week 4, 8, 12, 16, 20]

Percentage of Participants Achieving Modified Systemic Lupus Erythematosus (SLE) Responder Index (SRI) at Week 4, 8, 12, 16, 20, and 24 [Time Frame: Week 4, 8, 12, 16, 20, 24]

Percentage of Participants With Normalized Serological Activity [Time Frame: Baseline up to Week 24]

Serum Concentration of PF-04236921 [Time Frame: Day 1, Week 2, 4, 6, 8, 12, 16, 20, 24]

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) PCS and MCS at Week 4, 8, 12, 16, 20 and 24 [Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24]

Change From Baseline in Vitality Scores at Week 4, 8, 12, 16, 20 and 24 [Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24]

Percentage of Participants Achieving Pre-defined Criteria for Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Components at Week 24 [Time Frame: Week 24]

Change From Baseline in Patient Global Visual Analog Scale (VAS) at Week 2, 4, 6, 8, 12, 16, 20 and 24 [Time Frame: Baseline, Week 2, 4, 6, 8, 12, 16, 20, 24]

Number of Participants Who Discontinued Due to Adverse Events [Time Frame: Baseline up to Week 52]

Number of Participants With Potentially Clinically Important Vital Signs Findings [Time Frame: Baseline up to Week 52]

Percentage of Participants Achieving British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) Response at Week 4, 8, 12, 16, 20, and 24 [Time Frame: Week 4, 8, 12, 16, 20, 24]

Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline [Time Frame: Baseline]

Change From Baseline in Short Form-6 Dimension (SF-6D) at Week 4, 8, 12, 16, 20 and 24 [Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24]

Number of Participants With Clinically Significant Laboratory Tests Results [Time Frame: Baseline up to Week 52]

Number of Participants With Potentially Clinically Important (PCI) Electrocardiogram (ECG) Findings [Time Frame: Baseline up to Week 52]

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [Time Frame: Baseline up to Week 52]

Number of Participants With Treatment-Emergent Infectious Adverse Events (AEs) or Serious Adverse Events (SAEs) [Time Frame: Baseline up to Week 52]

Patient Global Visual Analog Scale (VAS) Scores at Baseline [Time Frame: Baseline]

Percentage of Participants With Corticosteroid Dose Reduced by Both Greater Than or Equal to (>=) 25 Percent (%) From Baseline and Less Than or Equal to (<=) 7.5 Milligrams Per Day (mg/Day) [Time Frame: Week 12, 16, 20, 24]

Thirty Six-Item Short-Form Health Survey (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Baseline [Time Frame: Baseline]

Secondary ID(s)

2011-000420-15

B0151006

BUTTERFLY

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/12/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01405196